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Normacol

Last Updated on eMC 06-Apr-2016 View changes  | Norgine Limited Contact details

1. Name of the medicinal product

NORMACOL.

2. Qualitative and quantitative composition

The active ingredient is Sterculia BP 62% w/w.

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Oral granules.

White irregular shaped granules.

4. Clinical particulars
4.1 Therapeutic indications

The treatment of constipation, particularly simple or idiopathic constipation and constipation during pregnancy .

Management of colostomies and ileostomies.

The 'High Residue Diet' management of diverticular disease of the colon and other conditions requiring a high fibre regimen.

The initiation and maintenance of bowel action after rectal and anal surgery.

Administration after ingestion of sharp foreign bodies to provide a coating and reduce the possibility of intestinal damage during transit.

4.2 Posology and method of administration

Posology

Adults: 1 or 2 sachets or 1-2 heaped 5ml spoonfuls, once or twice daily after meals

.

Older People : As adult dose.

Paediatric population

Children: (6-12 years): one half the above amount

NORMACOL is not recommended for children under 6 years of age

Method of administration

The granules should be placed dry on the tongue and without chewing or crushing, swallowed immediately with plenty of water or a cool drink. Prior to drinking they may also be sprinkled onto and taken with soft food such as yoghurt.

4.3 Contraindications

Intestinal obstruction, faecal impaction, and total atony of the colon.

Known hypersensitivity to the active substances or to any of the excipients listed in section 6.1

4.4 Special warnings and precautions for use

Caution should be exercised in cases of ulcerative colitis.

Patients with rare hereditary problems of fructose intolerance, glucose –galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Not to be taken immediately before going to bed or in a recumbent position especially in the elderly.

Not to be taken for more than 4 days if there has been no movement of the bowels.

It is not unusual for stool to appear paler in colour than normal as a result of local contact with sterculia. This does not indicate anything untoward.

Possible fluid and electrolyte depletion in association with diarrhoea.

Take with plenty of water to reduce the risk of oesophageal obstruction.

Adequate fluid intake should be maintained.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

NORMACOL may be recommended during pregnancyor lactation.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

,

System Organ Class

Adverse Drug Reaction

Immune system disorders

Allergic reactions

Gastrointestinal disorders

Oesophageal obstruction,

intestinal/colonic obstruction or impaction,

abdominal distension,

flatulence,

diarrhoea,

nausea,

abdominal pain

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Intestinal obstruction is possible in overdosage particularly in combination with inadequate fluid intake. Management is as for intestinal obstruction from other causes. If there is profound diarrhoea, dehydration and electrolyte depletion may occur.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Sterculia acts in the colon by forming a soft bulky stool and inducing a laxative effect.

5.2 Pharmacokinetic properties

Sterculia is not absorbed or digested in the gastrointestinal tract and its laxative action is normally effective within 12 hours of oral administration.

5.3 Preclinical safety data

There is no evidence that Sterculia has a significant systemic toxicity potential .

6. Pharmaceutical particulars
6.1 List of excipients

Sodium hydrogen carbonate

Sucrose

Talc

Hard paraffin

Titanium dioxide

Vanillin

6.2 Incompatibilities

None known.

6.3 Shelf life

Sachet and lined carton: 2 years

6.4 Special precautions for storage

Store in a dry place below 25°C.

6.5 Nature and contents of container

Sachet containing 7 g of white granules in boxes of 2, 7, 30 or 60 sachets.

Lined box of 100 g or 500 g of white granules.

Not all pack sizes may be marketed

6.6 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

Norgine Limited

Norgine House

Widewater Place

Moorhall Road

Harefield

UXBRIDGE

Middlesex UB9 6NS

United Kingdom

8. Marketing authorisation number(s)

PL 0322/5010R

9. Date of first authorisation/renewal of the authorisation

January 1991

10. Date of revision of the text

March 2016

Company contact details

Norgine Limited

Company image
Address

Norgine House, Widewater Place, Moorhall Road, Harefield, Middlesex, UB9 6NS

Fax

+44 (0)1895 825 865

Medical Information e-mail
Telephone

+44 (0)1895 826 600

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

sterculia

Legal categories

GSL - General Sales List

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